IVACAFTOR

Brand name:

• Kalydeco®

Pharmaceutical company:

VERTEX PHARMACEUTICALS (AUSTRALIA) PTY LTD

Condition/indication:
(therapeutic use)

• Cystic fibrosis (CF)

PBAC Submission type:

New PBS listing (Category 2)

Comment:

--

Public Summary Document:

Not yet available

Related medicines:

--

Submission received for:

March 2025 PBAC meeting

Opportunity for consumer comment:

Open 27/11/2024 and close 29/01/2025 (see PBS Website)

PBAC meeting:

Held on 12/03/2025

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

07/04/2025

Lodgement of required documentation:

14/04/2025

Acceptance of complete documentation:

Accepted

6Agreement to listing arrangements:

Commenced on 07/05/2025

Status:

Under consideration

7Government processes:

Has not yet commenced

8Medicine listed on the PBS:

Has not yet occurred

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